Gemcitabine Hydrochloride

ANDA 78433, held by Sun Pharm. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 78433 (Gemcitabine Hydrochloride), held by Sun Pharm, was first approved by FDA on Jul 25, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 25, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Gemcitabine HydrochlorideEQ 200MG BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Rx
Gemcitabine HydrochlorideEQ 1GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jul 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78433
Drugs@FDA: Overview at FDA
Company: Sun Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters